Comparison of paclitaxel in combination with cisplatin (TP), carboplatin (TC) or fluorouracil (TF) concurrent with radiotherapy for patients with local advanced oesophageal squamous cell carcinoma: a three-arm phase III randomized trial (ESO-Shanghai 2).

Abstract

INTRODUCTION:

Concurrent chemoradiation is the standard therapy for patients with local advanced oesophageal carcinoma unsuitable for surgery. Paclitaxel is an active agent against oesophageal cancer and it has been proved as a potent radiation sensitiser. There have been multiple studies evaluating paclitaxel-based chemoradiation in oesophageal cancer, of which the results are inspiring. However, which regimen, among cisplatin (TP), carboplatin (TC) or fluorouracil (TF) in combination with paclitaxel concurrent with radiotherapy, provides best prognosis with minimum adverse events is still unknown and very few studies focus on this field. The purpose of this study is to confirm the priority of TF to TP or TF to TC concurrent with radiotherapy in terms of overall survival and propose a feasible and effective plan for patients with local advanced oesophageal cancer.

METHODS AND ANALYSIS:

ESO-Shanghai 2 is a three-arm, multicenter, open-labelled, randomised phase III clinical trial. The study was initiated in July 2015 and the duration of inclusion is expected to be 4 years. The study compares two pairs of regimen: TF versus TP and TF versus TC concurrent with definitive radiotherapy for patients with oesophageal squamous cell carcinoma (OSCC). Patients with histologically confirmed OSCC (clinical stage II, III or IVa based on the sixth Union for International Cancer Control-tumour, node, metastasis classification) and without any prior treatment of chemotherapy, radiotherapy or surgery against oesophageal cancer will be eligible. A total of 321 patients will be randomised and allocated in a 1:1:1 ratio to the three treatment groups. Patients are stratified by lymph node status (N0, N1, M1a). The primary endpoint is overall survival and the secondary endpoint is progression-free survival and adverse events.

ETHICS AND DISSEMINATION:

This trial has been approved by the Fudan University Shanghai Cancer Centre Institutional Review Board. Trial results will be disseminated via peer reviewed scientific journals and conference presentations.

TRIAL STATUS:

The trial was initiated in July 2015 and is currently recruiting patients in all of the participating institutions above.

TRIAL REGISTRATION NUMBER:

NCT02459457.

• Authors: Dashan Ai, Yun Chen, Qi Liu, Junhua Zhang, Jiaying Deng, Hanting Zhu, Wenjia Ren, Xiangpeng Zheng, Yunhai Li, Shihong Wei, Jinjun Ye, Jialiang Zhou, Qin Lin, Hui Luo, Jianzhong Cao, Jiancheng Li, Guang Huang, Kailiang Wu, Min Fan, Huanjun Yang, Zhengfei Zhu, Weixin Zhao, Ling Li, Jianhong Fan, Harun Badakhshi, Kuaile Zhao
• Journal: BMJ open (BMJ Open) Vol. 8 Issue 10 Pg. e020785 (10 21 2018) ISSN: 2044-6055 [Electronic] England
• PMID: 30344165 (Publication Type: Clinical Trial Protocol, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Carboplatin
• Paclitaxel
• Cisplatin
• Fluorouracil

Topics

• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Carboplatin (administration & dosage)
• Chemoradiotherapy
• China
• Cisplatin (administration & dosage)
• Clinical Trials as Topic
• Esophageal Neoplasms (therapy)
• Esophageal Squamous Cell Carcinoma (therapy)
• Fluorouracil (administration & dosage)
• Humans
• Multicenter Studies as Topic
• Paclitaxel (administration & dosage)
• Randomized Controlled Trials as Topic
• Survival Rate
• Treatment Outcome